Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Biopsy-confirmed prostate adenocarcinoma of any stage/grade

• Prescribed or already receiving continuous ADT for \< 5 years

• Hemoglobin \> 11 g/dL

• Creatinine \< 1.5 x upper limit of normal (ULN), AST or ALT \<2 x ULN within 6 months prior to enrollment

• Liver function tests \< 2 x ULN

• Able to walk unassisted at least 100 meters (200 steps) or ECOG \<= 1

• No contraindications to any aspect of participation, including aerobic exercise

• Participant must be able to read, write, and understand the English language and be able to provide written consent

• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Locations
United States
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Time Frame
Start Date: 2019-05-02
Estimated Completion Date: 2029-05-02
Participants
Target number of participants: 50
Treatments
Experimental: Supportive care (diet, exercise, education)
Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
Related Therapeutic Areas
Sponsors
Leads: Roswell Park Cancer Institute

This content was sourced from clinicaltrials.gov